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..............Current Issue - December 2008.............
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Cover Story
Document Management - It's all about 'Staying in Control'
Dr. Sangeeta Aher's presentation at the National Conference on Clinical Trials, conducted by the CII in collaboration with ACRO and the Department of Science & Technology, Government of India, focused on the importance of document management control in clinical trials. This comprehensive presentation discussed various document types, their preparation, importance, and control. She emphatically stated that what is not documented is considered as not done; and quite often, essential documents are called 'essential' for nothing ...
- Dr. Sangeeta Aher
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SPOT LIGHT
Global Pharmaceutical Industry -
Further Attrition in Growth Rate for 2008, Industry Trends
With an estimated $ 712 billion in sales in 2007, the global pharmaceutical industry was up by 6.5% from 2006. Despite of sales gains being driven largely by price increases, increase in foreign exchange from a weaker dollar, and momentum from a few products introduced in 2006, the overall growth in 2007 was lesser than that of 2006 (7.0% from 2005). However, further attrition in growth rate is expected in 2008 mainly as several products are set to go off patent ...
- Frost & Sullivan
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IN FOCUS
BIOTECHNOLOGY
Autoimmune Responses:
An Attack on Self-Tissues
When the immune system mistakes self-tissues for non-self and mounts an inappropriate attack, the result is an autoimmune disease. Autoimmune diseases can each affect the body in different ways. For instance, the autoimmune reaction is directed against the brain in multiple sclerosis and the gut in Crohn's disease. In other diseases, such as systemic lupus erythematosus (lupus), affected tissues and organs may vary among individuals with the same disease ...
- Mr. Balram Parath
STRATEGY
Nurturing young entrepreneurs will create a wellspring of youthful,
dynamic leadership
Mr. Samprada Singh believes that although every business venture is basically profit oriented, retaining humanness and lending out a helping hand to those people who had been colleagues once upon a time and chose to move on for independence can eventually prove to be beneficial to both so as to grow together and develop a win-win situation. Respecting the individuality of the dynamic youth and supporting them in their entrepreneurial endeavors can go a long way in promoting industrial growth at large and facilitating healthy competition. Following are his views with regard to nurturing young talent for a better tomorrow ...
- Mr. Samprada Singh
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SPECIAL REPORTS
Cleanrooms - Going the Clestra Way!
Clestra Cleanroom, a European company with subsidiaries and customers all over the world, designs, fabricates, and installs cleanrooms intended essentially for the pharmaceutical industry. Its strategy is based on the manufacturing of finished partitions and ceiling elements to control the final quality. These elements are adapted to the specific process needs, from the initial design to the installation on site, thus meeting the user requirements and specifications (URS) ...
Medica Instruments - Instrumental in healthier and higher living
Medica Instrument Mfg. Co., a Mumbai-based manufacturer of medical instruments, is a registered SSI unit since 1967 with the Directorate of Industries and is also an ISO 13485:2003 certified organization. It is also a member of the Indian Pharma Machinery Manufacturers Association (IPMMA). The company's vision is to be a world-class organization in the healthcare industry, excelling in enduring and trusting customer relationships, built out of total customer satisfaction by giving solutions to the existing problems, anticipating future problems, and providing technological backup services on a continual basis to customers ... |
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CLINICAL RESEARCH
Cardiac Safety Studies: Thorough QT Studies
This article, based on Dr. Charu Gautam's presentation at the National Conference on Clinical Trials, discusses the need for cardiac safety studies for non cardiac drugs, drug-induced QT prolongation and Torsades de Pointes (TdP), the evolution of the regulatory agency as a response to criticism of delayed TdP-related market withdrawals, and ICH E 14 that insists on using 'Thorough QT/QTc' (TQTS) as a Litmus Test ...
- Dr. Charu Gautam
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